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Terminated

Boston Scientific SpyGlass Camera Ref Number: 4610 UPN M00546100

FDA Recall Z-0699-2007 · Posted 2007-03-31

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeKOG
Date Initiated2007-02-07
Date Terminated2007-11-15
Product Quantity12 units

Reason for Recall

A teal "bloom"/ glare on the subject image during high light conditions.

Firm Action

Boston Scientific notified accounts by letter dated 2/1/07 requesting return of product.

Root Cause

Other

Distribution Pattern

Nationwide Distribution --- including states of CA, CO, FL, OH, MA, MN, MO NY, PA, SC,TX, and WA .

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K971373VISTA SINGLE CHIP VIDEO CAMERAVista Medical Technologies, Inc. · 1997-05-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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